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Ambulatory nebulizer, non-heated - ARTG 469968

Access comprehensive regulatory information for Ambulatory nebulizer, non-heated in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 469968 and sponsored by TLC Diagnostics Pty Ltd, manufactured by Contec Medical Systems Co Ltd in China. The device registration started on November 22, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIb
ARTG 469968
Class IIb
Ambulatory nebulizer, non-heated
ARTG ID: 469968
Good Name: TLC Diagnostics Pty Ltd - Ambulatory nebulizer, non-heated
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Intended Purpose

An ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the nebulizer system, for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment to treat respiratory disorders such as Asthma or COPD.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
469968
Start Date
November 22, 2024
Effective Date
November 22, 2024
Manufacturer
Country
China
Address
No 112 Qinhuang West Street Economic & Technical Development Zone, Qinhuangdao, Hebei Province, 066004